MILEX® Pessary In-Service Training

02571_CPR_PessInServ_M2.qxp_Layout 1 9/2/14 4:42 PM Page 1
MILEX Pessary
In-Service Training
®
An educational resource provided by:
CooperSurgical is the leading company dedicated to providing medical devices and procedure
solutions that improve health care delivery to women regardless of clinical setting. Our company
is fostering that position through expansion of its core businesses and introduction of advanced
technology-based products which aid clinicians in the management and treatment of commonly
seen conditions.
800.243.2974 | 203.601.5200 | coopersurgical.com | 95 Corporate Dr. | Trumbull, CT 06611
Depend® is a registered trademark of Kimberly-Clark Worldwide, Inc.
Milex® is a registeres trademark of CooperSurgical, Inc.
©2014 CooperSurgical, Inc
81709 International
07/14
How you and your patients will benefit
from the use of pessaries
02571_CPR_PessInServ_M2.qxp_Layout 1 9/2/14 4:43 PM Page 3
SUPPORTIVE PESSARY SIZE CHART
DIAMETER MEASURED PESSARIES – ORDER BY SIZE
RING
WITH SUPPORT
INCONTINENCE
RING
INFLATOBALL
ABOUT COOPERSURGICAL
AS SHOWN IN THE YELLOW AREA
FLEXIBLE
GELLHORN
INCONTINENCE
DISH
DONUT
CooperSurgical is the leading company dedicated to providing medical devices and procedure solutions that improve health care
delivery to women regardless of clinical setting. Our company has fostered that position by expanding its core businesses through
the acquisition of over 30 product lines, and introduction of advanced technology-based products which aid clinicians in the
management and treatment of commonly seen conditions.
SHAATZ
CooperSurgical products fall into three main segments based on the point of health care delivery: Hospital, Office and Clinic. Our
customers are health care professionals and institutions providing care to and for women.
51
2
3
2 1/4"
2 1/2"
57
64
4
2 3/4"
70
5
3"
76
6
3 1/4"
83
mm.
1 3/4"
44
1
2"
51
2
2 1/4"
3
57
2 1/2"
64
4
2 3/4"
70
5
3"
76
6
3 1/4"
SIZE
Inch.
mm.
S
2"
51
M
2 1/4"
57
L
2 1/2"
64
2 3/4"
XL
SIZE in
Inches
mm.
70
DIAMETER
100% LATEX
83
7
3 1/2"
89
7
3 1/2"
89
8
3 3/4"
95
8
3 3/4"
95
9
4"
102
9
4"
102
10
4 1/4"
108
10
4 1/4"
108
11
4 1/2"
114
11
4 1/2"
114
12
4 3/4"
121
12
4 3/4"
121
13
5"
127
13
5"
127
MEASURE ACROSS
2"
51
2 1/4"
57
2 1/2"
64
2 3/4"
70
3"
76
3 1/4"
83
3 1/2"
89
3 3/4"
95
FOR OUTSIDE
DIAMETER
SIZE in mm.
55
60
65
70
75
80
Shaatz • KPSH
2"
Inch.
0
Incontinence Dish • KPCOND
1
SIZE
Donut • KPDO
44
Inflatoball • KPINF
mm.
1 3/4"
Incontinence Ring • KPCON
Ring with Support • KPRS
Inch.
0
Flexible Gellhorn • KPGE
*
*
SIZE
Our company is committed to continued expansion of its core business through internal development programs and acquisition
strategies. Since its inception in 1990, CooperSurgical has steadily grown its market presence and distribution system by developing
and purchasing products and acquiring companies that complement its business focus. The company now has an established
customer base serving well over 65% of women's health care providers with sales exceeding $200 million. Our focus is on women’s
health. Our mission is to advance the well-being of women by offering health care solutions based on sound clinical results. Our
result is value creation.
SIZE in
Inches
mm.
85
DIAMETER
DIAMETER
1 1/2"
38
1 3/4"
44
2"
51
2 1/4"
SIZE in
Inches
mm.
1 1/2"
38
1 3/4"
44
2"
51
57
2 1/4"
57
2 1/2"
64
2 1/2"
64
2 3/4"
70
2 3/4"
70
3"
76
3"
76
3 1/4"
83
3 1/4"
83
3 1/2"
89
3 1/2"
89
3 3/4"
95
3 3/4"
95
DIAMETER
We are happy to provide these training services to health care professionals. This in-service training is designed to help you better
understand all aspects of pessary use. Feel free to call your CooperSurgical Territory Manager with any questions or needs you
may have.
MILEX® PESSARY IN-SERVICE
DIAMETER
*Remember for sizing: The incontinence knob available for this pessary adds 1/2 inch (13 mm) to the diameter.
1
2
3
4
5
DIAMETER
DIAMETER
Inches
Centimeters
All pessaries may be ± 1%
1
CUBE KPEC
SMITH
KPES
A
SIZE
Inch.
mm.
0
1"
25
1
1 3/16"
30
2
1 3/8"
35
3
1 1/2"
38
4
1 5/8"
41
5
1 3/4"
44
HODGE
6
2"
51
KPEH
7
2 1/4"
57
B
A
B
*
2
3
4
SIZE
In.(A)
In.(B)
mm.(A)
mm.(B)
0
3 1/8"
2"
79
51
1
3 1/4"
2 1/8"
83
2
3 1/2"
2 1/4"
3
3 3/4"
2 3/8"
4
4 1/4"
5
5
6
GEHRUNG
7
8
9
10
11
12
13
SIZE
In.(A)
In.(B)
In.(C)
mm.(A)
mm.(B)
mm.(C)
0
1 1/16"
1 1/2"
1 3/8"
27
38
35
54
1
1 1/8"
1 3/4"
1 1/2"
29
44
38
89
57
2
1 3/8"
2"
1 5/8"
35
51
41
95
60
3
1 1/2"
2 1/8"
1 3/4"
38
54
44
2 1/2"
108
64
4
1 5/8"
2 1/4"
1 7/8"
41
57
48
4 1/2"
2 5/8"
114
67
5
1 3/4"
2 3/8"
2"
44
60
51
6
4 3/4"
2 3/4"
121
70
6
1 7/8"
2 1/2"
2 1/8"
48
64
54
7
5"
2 7/8"
127
73
7
2"
2 7/8"
2 1/4"
51
73
57
8
5 1/2"
3"
140
76
8
2 1/8"
3"
2 3/8"
54
76
60
9
5 3/4"
3 1/8"
146
79
9
2 1/4"
3 1/8"
2 1/2"
57
79
64
10
2 3/8"
3 1/4"
2 5/8"
60
83
67
SIZE
In.(A)
In.(B)
In.(C)
mm.(A)
mm.(B)
mm.(C)
25
49
35
27
51
38
KPGS
A
*
C
REGULA
B
SIZE
In.(A)
In.(B)
mm.(A)
mm.(B)
0
2 3/4"
1 3/4"
70
44
0
1"
1
3"
1 7/8"
76
48
1
11/16"
2
3 1/4"
1 15/16"
83
49
2
3
3 1/2"
2"
89
51
3
4
3 5/8"
2 1/8"
92
54
4
5
3 3/4"
2 1/4"
95
57
5
6
3 7/8"
2 3/8"
98
60
6
1 1/2"
7
4 1/4"
2 1/2"
108
64
7
1 5/8"
8
4 5/8"
2 5/8"
117
67
8
1 3/4"
9
5"
2 3/4"
127
70
SHADED AREA SHOWS MINIMUM ASSORTMENT NECESSARY TO FIT 85+% OF PATIENTS
KPREG
1 15/16" 1 3/8"
2"
1 1/2"
1 1/8"
2 1/8"
1 5/8"
29
54
41
1 1/4"
2 3/16"
1 3/4"
32
56
44
1 3/8"
2 1/4"
1 7/8"
35
57
48
1 7/16"
2 3/8"
2"
37
60
51
2 5/8"
2 1/8"
38
67
54
2 7/8"
2 1/4"
41
73
57
3 1/8"
2 3/8"
44
79
60
Composition:
Milex brand of pessaries from CooperSurgical are made of non-toxic medical-grade silicon.* Milex Pessaries are available in 27 styles, each
having a range of sizes to ensure optimal fit and comfort for the patient. The Milex pessaries are made in the U.S.A. and are manufactured
in pink for single patient use; a limited variety of products are produced in yellow for use by the clinician when fitting the patient.
Benefits of the Milex nontoxic medical grade silicone:
• Milex silicone provides high consistency elastomers designed for optimal performance
• Milex silicone does not absorb odors or secretions and has a longer shelf and use life
• Milex silicone significantly reduces the chance of an allergic reaction
• Milex silicone can withstand repeated sterilization by autoclaving
Note: All pessaries, when new, are coated with a corn starch powder and must be washed off with a mild soap and thoroughly rinsed prior to initial use.
Prior to insertion of any pessary it is important to thoroughly clean and remove any matter that may be on the outer surface.
CooperSurgical recommends washing with mild soap and thoroughly rinsing with water prior to initial use. Although there is no need
to sterilize the pink pessary for single patient use, if the bag is open a sterilization cycle maybe performed to provide an extra
degree of assurance when initially fitting the pessary. We find this practice is a good policy to avoid any inadvertent contamination.
The yellow pessaries are designed to be used for selecting and fitting the right pessary for individual patient use and should only be
worn in 15 minute increments. CooperSurgical strongly recommends and advises the yellow fitting pessary be
sterilized prior to fitting each patient.
With the realization that many different techniques are practiced in the health care community, we attempted to optimize methods
to afford the best coverage for our customers. It is vital that every facility fully validate its own equipment and parameters before
processing any medical device.
CLEANING:
• Decontamination/Disinfection: CIDEX OPA for 12 minutes
• The agent must be thoroughly rinsed off with water
STERILIZATION:
• Pre-vacuum parameters of 132ºC +3ºC for 4 minutes
• Gravity Displacement parameters of 121ºC +3ºC for 40 minutes
The same validated sterilization parameters are to be used for both the pink and yellow products as they are manufactured from the
same medical grade silicone-based resin. The only difference between the two products is the color additive; both have been
challenged for cytologic and biologic compliance. The pink Ring pessaries come with nylon pegs for support, while the yellow fitting
Ring pessaries do not.
*Inflatoball made of 100% latex.
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WHEN IS A PESSARY INDICATED?
Patients are candidates for a pessary when…
Have patient report any of the following symptoms:
•
Difficulty urinating
•
Change in color or consistency of vaginal discharge
•
There is a need to postpone having surgery
•
Marked increase in vaginal discharge
•
The patient is a poor surgical candidate – underlying medical problems, age, etc.
•
Foul odor associated with vaginal discharge
•
A pessary may be used as a diagnostic tool for physicians to determine if surgery will correct the problem
•
Vaginal itching
•
The use of a pessary may provide temporary relief while awaiting surgery
•
It may hasten postoperative healing: Wearing a pessary prior to surgery helps relieve congestion
of mucosa and improves circulation to the area
To properly fit a patient with a supportive pessary, it is recommended to have on hand a minimum of four of the most commonly
used sizes.
•
A patient refuses surgery
•
If the patient plans on having children in the future
Fitting diaphragms do not accurately measure the pessary size that the patient will need. Diaphragms fit differently from pessaries.
Even before fitting a pessary, the patient should be informed that it is not uncommon to have to change the size or type of pessary
more than once after being originally fitted. This is why it is so important that your patient be instructed to return within 24 hours of
the initial fitting and again in 72 hours.
Contraindication to supportive pessaries:
•
Local infections – Active infections of the vagina or pelvis, such as vaginitis or pelvic inflammatory disease,
preclude the use of a pessary until the infection has been resolved.
•
Noncompliance – Noncompliance with follow-up could be harmful since an undetected and untreated
erosion could put the patient at risk of developing a fistula.
•
Inability to manage the pessary – Sexually active women who are unable to remove and reinsert the pessary
Prior to fitting a pessary, have the patient empty her bladder.
EXCEPTION: Incontinence pessaries should be fitted before the patient voids.
Irrigation of the vagina to remove excess secretions and discharge should be considered prior to insertion of a pessary.
Perform a normal pelvic examination before fitting any pessary.
If necessary, the insertion end of the pessary can be coated with a suitable lubricant. Be sure to only coat the insertion end as the
pessary may get too slippery to handle properly if it’s coated entirely.
PESSARY MAINTENANCE AND FOLLOW-UP RECOMMENDATIONS
•
Make sure the patient immediately reports any discomfort
•
Have patient return within 24 hours for first exam
•
Return again within three days for the second exam
•
Return every four to six weeks per clinicians discretion for regular re-exams
These are recommendations and may be adjusted to suit the needs of the patient and the physician.
During each visit:
1. Remove pessary
2. Carefully examine vaginal vault to ensure there is no area of pressure necrosis, ulceration or allergic reaction.
The patient should be questioned concerning discharge, disturbance of bowel function or urination. It may
be necessary to fit another size or an entirely different type of pessary
3. Clean pessary with mild soap and water. Rinse thoroughly before reinserting.
4. A vaginal irrigation should be considered prior to initial insertion of the pessary
5. Reinsert pessary. DO NOT assume that a replacement will be the same size as the previous one. Check the fitting
to ensure patient comfort and relief of symptoms. At each checkup, the pessary is removed and cleaned. If there
are no contraindications, the pessary is reinserted
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1ST OR 2ND DEGREE PROLAPSE PESSARIES
Recommendations: Ring, Ring with Support, Shaatz or Regula
All of the above are made from medical-grade silicone.
RING: Positioned similar to a contraceptive diaphragm. To size – the length of the vaginal vault is
measured with the examining finger and the size of the pessary is approximated to your fingers.
Measure the distance from the posterior fornix to the pubic notch and note where that is on your
finger. To insert the Ring pessary, fold it so that the arc points downward and is directed past the
cervix into the posterior fornix. It will spring open once released. A one-quarter turn of this pessary
is recommended to prevent it from folding and being expelled. The examining finger should be able
to sweep between the vaginal wall and the ring pessary. If there is too much or too little space the
pessary must be removed and another size inserted. After fitting the pessary the patient should
stand up and bear down. The pessary should not be so loose that it can be expelled nor should it
be so tight that it causes any discomfort.
RING WITH SUPPORT: This pessary is recommended if the patient has a mild cystocele
accompanying her mild prolapse. It is fitted the same as the regular Ring pessary. The patient
should have a well-defined pubic notch to retain a Ring pessary.
REGULA: Indicated for patients who have a first or second degree prolapse when there is an
ill-defined pubic notch. The Regula’s unique design is flexible and can be molded for a perfect fit.
Furthermore, the Regula’s design helps prevent expulsion due to the pressure from the prolapse being
directly transferred from the pessary’s arch to its spreading legs. Insert the pessary by bringing the heels
together. Use one finger of opposing hand to press down on the perineum, insert the pessary with
both legs (of the pessary) compressed so prolapse rests behind the arch.
To remove the Regula, compress the heels of the pessary together while applying downward pressure
on perineum with finger of opposing hand and gently remove.
2ND OR 3RD DEGREE UTERINE PROLAPSE PESSARIES
Recommendations: Donut, Gellhorn, Inflatoball, Cube and Tandem-Cube
DONUT: This is one of the most frequently used pessaries. It is made of medical-grade silicone and
is autoclavable. This pessary is inserted and removed inflated. The size is determined primarily by the
width of the vaginal vault. Using the finger(s) of one hand, compress the Donut. Then, with the other
hand, gently press down on the perineum. Bring the compressed Pessary on an angle until it is almost
parallel with the introitus. Guide the pessary into the vaginal vault and gently push it up until the
cervix rests behind the Donut hole and supports the weight of the uterine prolapse. The pessary should
be large enough to support the uterus. Once in position, the patient should not feel the pessary. If
she feels the pessary, she needs a smaller size or another type of pessary. Center hole allows for
adequate drainage.
To remove Donut, loop a finger into the Donut hole, bringing it down and angling it until it is almost
parallel with the introitus. Using finger(s) of the other hand to press down on the perineum, compress
the Donut and remove.
RING WITH SUPPORT and KNOB: This pessary is recommended if the patient has a mild
cystocele accompanying her mild prolapse as well as stress urinary incontinence. It is fitted the
same as the regular Ring pessary. The patient should have a well defined pubic notch to retain a
Ring pessary.
To remove a Ring pessary, turn the pessary so that the notched area (by the large holes) is facing
the introitus. Fold the pessary by notched area, thereby bringing un-notched sides together, and
withdraw pessary in a folded position.
SHAATZ: Indicated for patients who have a first or second degree prolapse with a mild cystocele.
The Shaatz is ideal for the patient who has a shallow pubic notch and cannot retain a ring pessary,
OR for the patient who has developed pressure necrosis of the pubic notch with a Ring pessary. The
Shaatz uses the levator muscles to hold it in place. The holes in the pessary allow for drainage
without reducing its effectiveness. The width of the vaginal vault helps determine the size of the
Shaatz needed. The Shaatz requires a capacious vaginal vault. The cervix rests behind the disc of
the pessary.
To remove the Shaatz, insert one finger into the large hole to bring the pessary down toward the
introitus. Turn the pessary so that the rim is almost parallel to the introitus. With one or two fingers
of the other hand, press down on the perineum and slide the pessary out.
GELLHORN: The Gellhorn pessary provides support for 3rd degree Uterine Prolapse/Procidentia. The
Gellhorn is available in flexible medical-grade silicone and 95% rigid silicone. Additionally, the
Gellhorn is available with a regular stem and short stem – dependent on the vaginal length. Many
clinicians find the flexible silicone Gellhorn easier to insert and remove. Some clinicians like the more
rigid Gellhorn but want to be able to re-sterilize the pessary by autoclaving; this makes the 95% rigid
silicone pessary ideal.
All Gellhorn pessaries require the patient to have a relatively capacious vagina so that the base of the
pessary is broad enough to rest above the levator muscles with the cervix resting behind the flat disk.
The stem helps prevent the pessary from turning/flipping. The stem is visible at the introitus when the
patient bears down. To help approximate the size needed, measure the width of the vaginal vault using
your fingers. This should get you to within a size or two needed.
To insert the Gellhorn pessary, grasp the knob, squeeze toward the disk, and hold the disk portion
parallel to the introitus. With a finger of the other hand, press down on the perineum. Rotate the disk
over the perineal body (barber-pole action), gently pushing the pessary up until the cervix rests behind
the disk and the stem is inside the vagina. You should be able to see the end of the stem when the
patient bears down. The holes in the disk and the stem allow for adequate drainage.
To remove the Gellhorn, grasp knob and gently pull pessary down while turning the pessary so that
the disk is parallel to the introitus. If needed, place finger behind the disk to break suction with a finger
from the other hand, press down on the perineum and while using the barber-pole action, gently
rotate the pessary out through the introitus.
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INFLATOBALL:The Inflatoball pessary is made of 100% latex. The Inflatoball pessary is recommended
for 3rd degree uterine prolapse/procidentia with or without a mild cystocele or rectocele. The
inflatoball should be removed nightly, washed with a mild soap and thoroughly rinsed. If possible, leave
the pessary out at night. Step-by-step patient instructions are included with each pessary shipped.
The Inflatoball pessary is inserted while deflated with the bulb attached to the stem. It is positioned
by the patient as high as her fingers can reach. Once in position, the patient inflates the pessary by
compressing the bulb, usually four to five times (do not over-inflate). Before the bulb is detached from
the stem, move the “bead” resting at the base of the stem up about 1 to 2 inches as this
prevents air from escaping. The bulb is then detached and the stem can be tucked into the vagina.
The Inflatoball pessary is available in four sizes: small, medium, large and extra-large. The size is
determined by the width of the vaginal vault.
Check the fitting of all of the above pessaries to ensure patient comfort and relief of symptoms.
A properly fitted pessary will permit the index finger to sweep around between the pessary and
the vaginal wall.
CYSTOCELE AND RECTOCELE
Recommendations: Gehrung, Gehrung with Knob
GEHRUNG AND GEHRUNG WITH KNOB: The Gehrung pessary is indicated in those women
with cyctocele with or without rectocele and, in the case of the Gehrung with Knob, when those
conditions are complicated by stress urinary incontinence. It supports a cystocele and thins out
a rectocele. The Gehrung derives its support from the lateral remnants of the levator sling, thus
avoiding pressure on the rectum. Because of the folding design, the pessary size necessary for
adequate support can be inserted even when the introitus is narrow. The Gehrung also provides
broad support under the bladder and helps prevent the descent of the uterus. To insert, shape
to desired size. Fold, insert and rotate into position behind the cystocele and, in the case of the
Gehrung with Knob, with the knob supporting the urethrovesical junction (UVJ).
To remove the Gehrung and Gehrung with Knob, rotate and remove leg first.
To remove the pessary, push the “bead” down to the closed end of the stem to permit air to escape
from the pessary. Now grasp the deflated pessary and withdraw. DO NOT pull on the pessary stem
as this can be more traumatic to the patient.
During each visit, the vagina should be carefully inspected for evidence of pressure or allergic reaction.
The patient should be questioned concerning discharge, disturbance of bowel function or urination.
It may be necessary to fit another size or an entirely different type of pessary.
DO NOT assume that a replacement will be the same size as the previous one. Check the fitting to
ensure patient comfort and relief of symptoms.
At each checkup, the pessary is removed and cleaned. If there are no contraindications, the pessary
is reinserted.
CUBE: (Flexible, Silicone): The Cube pessary is indicated in those women with 3rd degree uterine
prolapse/procidentia, mild cystocele, rectocele, vaginal wall prolapse and/or poor vaginal muscle tonicity. Women who are unable to retain any other type or shape pessary are candidates for the Cube.
To help determine the size pessary needed, approximate the width of the vaginal vault. The Cube has
6 concavities that adhere to the vaginal walls by suction thereby holding the uterus, bladder, and vaginal walls in position. The Cube has no area for drainage. In addition, the negative pressure builds
up, making it more difficult to break the suction in order to remove this pessary. This is why it is so
important to remove the Cube pessary nightly and, if possible, leave it out overnight.
The Cube pessary is also recommended for young women who only have urine leakage when
engaged in strenuous physical activity such as aerobics, jogging, tennis, etc. The ease of insertion and
removal allow for use of the Cube only during the limited time of heightened activity.
To remove the Cube, work two or three fingers between the pessary and the vaginal wall to break
the suction. Pinch the pessary and remove – DO NOT PULL ON THE SILICONE STRING! The silicone
string allows for ease in locating the pessary for removal. Pulling the string to remove the Cube
pessary can traumatize the tissue and result in string breakage.
TANDEM-CUBE: (Flexible, Silicone) is indicated in the patient with a long vaginal vault where a
single Cube pessary will not prevent the uterus, bladder and/or vaginal walls from prolapsing. This
pessary consists of two Cubes fused together; the entering Cube is 2 sizes larger than the proximal
Cube allowing for 10 concavities adhering by suction to the vaginal walls. Follow the same protocol as
with the Cube for Tandem-Cube removal.
Important: Have the patient insert and remove the Cube or Tandem-Cube pessary several times while she is in the doctor’s office to be
sure that she can handle the pessary once she gets home. If the patient is unable to insert and remove the pessary as directed we strongly
advise against the use of the Cube or Tandem-Cube pessary.
INCONTINENCE PESSARIES
Incontinence is the loss of bladder or bowel control. It affects women of all ages. It is NOT a disease. It is NOT a part of being a woman.
It is NOT a consequence of getting old. The statistics are: one out of four women over the age of 40 experiences some degree of
incontinence. Over 13 million Americans are affected by it. A patient may dribble only a few drops when they laugh, cough or
sneeze (usually they quickly cross their legs or sit down). They may leak constantly or empty their entire bladder without any
warning. Therefore, the problem has social implications. They may stop leaving the house, going for car rides, exercising or having
sexual intercourse.
It has been estimated that approximately 2% of health care costs in the U.S. are spent on incontinence-related care. Usually, patients
will start out using Mini or Maxi pads and may progress to using Depend®-type adult diapers. The cost of these Depend®-type
products is about $1.00 each. If a patient uses two to three a day, the expense can amount to $730 to $1,095 per year.
Medical costs due to the problem of incontinence are estimated at $10 billion per year in the United States.
There are different types of incontinence: Stress, Urge, Overflow or a combination of types. The most common type is stress urinary
incontinence.
Stress urinary incontinence (SUI) is the involuntary loss of urine with physical activity such as coughing, sneezing, laughing, jogging
or aerobics.
The trauma of childbirth and aging cause a partial interruption in the nerve impulse route (denervation), resulting in a decrease in, or
even no, transmission of impulses through the pathways to the pelvic floor muscles. The muscle tissue so denervated, atrophies and
becomes weaker.
The levator ani muscles support the pelvic organs and form the platform to which the pelvic ligaments are attached. Delayed
conduction of impulses to the pelvic floor muscles are seen in women with SUI.
At the level of the urethra, urinary continence exists when pressure in any part of the urethra is the same as or greater than the “pressure
in the bladder. Conversely, when the pressure is lower in the urethra than in the bladder, urinary incontinence occurs.
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Stress urinary incontinence may be due to intrinsic sphincter deficiency (ISD), affecting patients with impaired sphincter function. For
women with ISD and a lack of urethral mobility, periurethral bulking agents such as collagen injections provide a successful alternative
to abdominal or vaginal surgery.
Genuine stress incontinence (GSI), one of the most common causes of stress urinary incontinence, is primarily due to hyper
mobility of the urethra. An alternative to surgery for the woman with GSI due to hypermobility of the urethrovesical junction is the use
of an incontinence pessary. The pessary restores continence by stabilizing the bladder base, allowing proper pressure transmission to
the urethra, and by active enhancement of urethral resistance through significantly increased urethral functional length and closure
pressure.
Pessaries are used therapeutically as an alternative to surgical repair in those patients where surgery is contraindicated. Frail, elderly
women, those with major health problems, young women who plan to have more children in the future as well as those women who
refuse to have surgery are all candidates for pessary use.
Pessaries are also used preoperatively as a test in patients with marked cystocele, vaginal vault prolapse, or procidentia to determine if,
when these conditions are corrected with a pessary, the patient develops stress incontinence. This will help determine if correction of
the urethrovesical junction defect at the time of surgery for prolapse should be performed.
The type of pessary you choose for a given patient is determined by the anatomic defect and the symptoms exhibited by the patient.
All incontinence pessaries should be fitted before the patient empties her bladder.
A diagnostic test is performed to help determine if the patient would benefit from an incontinence pessary. This is known as the
Marshall-Marchetti, or Bonney Test.
1.
Patient with a full bladder standing in an erect position is asked to cough.
2.
If short spurts of urine escape simultaneously with each cough, SUI is suggested.
3.
The bladder neck is elevated with one finger on each side of the urethra and the patient is asked to cough.
4.
If there is no loss of urine when the patient coughs, the test is considered to be positive and the patient
would benefit from using a pessary device.
Experience has shown that in order to properly fit a pessary, you should have at least one of each of the four most commonly used sizes
in any given pessary.
Fit patient with the largest size pessary that can be inserted without causing any undue discomfort.
INCONTINENCE RING: The Incontinence Ring pessary is indicated in those women with urinary
stress incontinence. It helps restore continence by stabilizing the bladder base. The pessary’s “knob”
keeps gentle pressure on the urethrovesical junction (UVJ) by enhancing the urethral resistance through
increased urethral functional length and closure pressure. To insert, hold the pessary almost parallel
with the introitus. Direct the entering end of the pessary (opposite side of the knob) past the cervix
into the posterior fornix. Use the index finger to bring the knob up behind the symphysis pubis.
To remove the Incontinence Ring, use the index finger of opposing hand to depress the perineum,
hook index finger under knob and gently pull down.
INCONTINENCE DISH: The Incontinence Dish pessary is indicated in those women with urinary
stress incontinence concomitant with 1st or 2nd degree prolapse. It stabilizes the UVJ and increases
closure pressure. To insert, hold the pessary almost parallel with the introitus. Direct the entering end
of the pessary (opposite side of the knob) past the cervix into the posterior fornix. Use the index
finger to bring the knob up behind the symphysis pubis.
To remove the Incontinence Dish, use the index finger of opposing hand to depress the perineum,
hook index finger under knob and gently pull down.
INCONTINENCE DISH WITH SUPPORT: The Incontinence Dish with Support pessary is indicated
in those women with urinary stress incontinence concomitant with 1st or 2nd degree prolapse
complicated by a mild cystocele. It stabilizes the UVJ and increases closure pressure and includes holes
for drainage without decreasing the effectiveness of the pessary. To insert, hold the pessary
almost parallel with the introitus. Direct the entering end of the pessary (opposite side of the knob)
past the cervix into the posterior fornix. Use the index finger to bring the knob up behind the
symphysis pubis.
To remove the Incontinence Dish with Support, use the index finger of opposing hand to depress the
perineum, hook index finger under knob and gently pull down.
LEVER SUPPORT PESSARIES
HODGE, SMITH, AND RISSER: The Hodge, Smith and Risser pessaries are typically referred to as
the “lever support pessaries”. From a historical point of view, the lever pessary dates back to
the late 1800s following Hugh Lenox Hodge’s (Professor of Gynecology at the University of
Pennsylvania) dissatisfaction with the circular designs of the day. The oblong and curved shape of
the Hodge pessary corresponded with the curvature of the vagina and was able to be positioned so
that it treats uterine retroversion by posteriorly displacing the cervix and anteverting the uterus. The
Smith pessary has a narrower anterior edge for applicaton in a patient with a narrow pubic arch. The
Risser is designed for a patient with an even more narrow pubic arch. Although originally designed
to treat uterine retroversion, these lever pessaries currently are used for the treatment of an
incompetent cervix in pregnancy (sometimes along with a cervical cerclage), for mild prolapse with
retroversion, and as a diagnostic maneuver in evaluation of patients with large cystoceles. The Hodge
with Support and Knob will also stabilize the UVJ for patients with stress urinary incontinence.
To insert a lever pessary, first manually elevate the retrodisplaced uterus. The pessary is then folded
and inserted into the vagina by the index finger, pressing on the posterior edge of the pessary until
it is behind the cervix with the anterior edge of the pessary resting behind the pubic notch.
To remove a lever pessary, use the index finger of opposing hand to depress the perineum, hook index
finger under the anterior edge of the pessary and gently pull down.
ENDING NOTES - PESSARY REIMBURSEMENT
The fitting/insertion of the pessary and the pessary itself are reimbursable. CPT code 57160
(“fitting and insertion of pessary or other intravaginal support device”) is used to report the
physician’s service of fitting and inserting the pessary. HCPCS code A4562 (“pessary, nonrubber,
any type”) should be reported for the supply of the Pessary. Additional CPT codes that may be
used are 99201-99215 (office visit code) and 57150 (vaginal irrigation). Check with your
regional Medicare provider for additional details.